mUC Indication for Atezolizumab Voluntarily Withdrawn from US Market by Roche


Atezolizumab (is being voluntarily withdrawn from the US market by Roche for its indication as a treatment for patients with prior-platinum treated metastatic urothelial carcinoma.

Atezolizumab (Tecentriq) is being voluntarily withdrawn from the US market by Roche for its indication as a treatment for patients with prior-platinum treated metastatic urothelial carcinoma (mUC), according to a press release by the company.1

The decision was made in consultation with the FDA as part of an industry-wide review of agents granted accelerated approvals but that did not meet their primary end points in the required confirmatory trials. Roche plans to meet with the FDA in order to complete the withdrawal process.1

Atezolizumab is a monoclonal antibody that is designed to bind with a protein known as programmed death ligand-1 (PD-L1), which is expressed in tumor cells and tumor-infiltrating immune cells. The drug is designed to block its interaction with both PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab will hopefully activate T cells. Additionally, the drug can potentially be used as a combination partner with other immunotherapies.1

Atezolizumab was granted accelerated approval by the FDA in 2016 based on positive data from cohort 2 of the phase 2 IMvigor210 study (NCT02108652). Atezolizumab led to an objective response rate of 15% (95% CI, 11%-19%) in the study, with response ongoing in 84% of responders at data cutoff.2 Continued approval of atezolizumab for the mUC indication was contingent on the results of the IMvigor211 study (NCT03620435). The study did not meet its primary end point of overall survival in the PD-L1–high patient population.3

The phase 3 study compared the efficacy and safety of atezolizumab versus chemotherapy in patients 18-year-old or older with mUC that had progressed after platinum-based chemotherapy. Patients were randomly assigned 1:1 to receive either 1200 mg of atezolizumab or chemotherapy (physicians’ choice) intravenously every 3 weeks. Of the evaluable patients, 23% of the atezolizumab group achieved an objective response. In the chemotherapy group, 22% achieved an objective response group.

Duration of response was numerically longer in the atezolizumab group than the chemotherapy group (15.9 vs 8.3 months). Additionally, the group had fewer grade 3-4 treatment-related adverse events (20% vs 43%) and fewer adverse events leading to treatment discontinuation (7% vs 18%).

“The Accelerated Approval Program allows people with difficult-to-treat cancers to receive certain new therapies earlier,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development, in a press release. “While the withdrawal of Tecentriq for prior-platinum treated bladder cancer is disappointing, Tecentriq continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients.”1

According to the press release, this decision will not affect other indications for atezolizumab. Patients with prior platinum-treated mUC who are currently taking atezolizumab should discuss their treatment with their health care provider.

  1. Roche provides update on Tecentriq US indication in prior-platinum treated metastatic bladder cancer. News Release. Roche March 8, 2021. Accessed March 8, 2021.
  2. FDA grants Roche’s TECENTRIQ® (atezolizumab) accelerated approval as initial treatment for certain people with advanced bladder cancer. News Release. April 18, 2017. Accessed March 8, 2021.
  3. Powels T, Durán I, Heijden M, et al. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2018;391(10122):748-757. doi:10.1016/S0140-6736(17)33297-X
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